FM Manufacturing Engineer II

Freudenberg Group; Jeffersonville (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

Freudenberg Group is seeking an experienced Manufacturing Engineer to guide development and optimization of medical device production processes in a regulated environment. You will ensure ISO/GMP compliance, create robust work instructions, BOMs, and process flowcharts, and coordinate equipment qualification activities.

The role requires 3+ years in a regulated industry, strong problem-solving, and cross-functional collaboration to meet timelines, costs, and quality targets.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ years in a regulated industry (medical devices).
• Experience with ISO 13485, ISO 14971, GMP principles.
• Knowledge of process validation and DOE studies.
• Familiarity with QC/QA documentation.

Responsibilities

• Lead development and optimization of manufacturing processes.
• Maintain manufacturing docs: BOMs, flowcharts, work instructions.
• Coordinate IQ/OQ/PQ of equipment and fixtures.
• Participate in production meetings and meet cost targets.
• Communicate with customers/suppliers on issues.
• Train operators and sustain improvements.
• Lead Lean/Six Sigma projects and Kaizen.
• Train new team members as needed.

Skills

Lean Six Sigma

Root cause analysis

Process optimization

Regulatory compliance

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

DOE

Process validation

Mold design

Job description

Working at Freudenberg: We will wow your world!

Responsibilities:

• Guide the development and optimization of manufacturing processes, including tooling design and process characterization in compliance with ISO standards, country-specific and GMP regulations.

• Develop and maintain detailed manufacturing documentation, including BOMs, process flowcharts, work instructions, and test/inspection plans in compliance with quality system requirements.

• Specify and coordinate the procurement, installation, and qualification (IQ/OQ/PQ) of manufacturing equipment, fixtures, and gauges to support efficient and reliable production.

• Participate in daily production meetings (i.e., LPMS) and collaborate with operations and customer service to ensure project timelines, production goals, and cost targets are met.

• Proactively communicate with customers and suppliers on project matters, mold and fixture design/repair, validation, and product quality issues.

• Train and support technicians and operators through ongoing sustaining engineering activities.

• Analyze and solve manufacturing issues using a structured, root-cause problem-solving approach and lead cross-functional teams to implement robust, permanent solutions.

• Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost; oversee Kaizen initiatives and eliminate waste in manufacturing processes.

• May help train new team members.

Qualifications:

• Bachelor’s/University degree in Engineering, Chemistry, Biology, or related science/technical field.

• 3+ years’ experience in a regulated industry.

• Proficiency in manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.

• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.

• Thorough understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971. Proficiency in GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).

• Understanding of process validation principles and process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.

• Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.

• Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC